The MES Solution
by John Dzelme, Global Chief Operating Officer
Seabrook Technology Group
The ever-changing landscape of the Life Sciences sector creates numerous challenges for medical device manufacturers. Increasing cost pressures, diminishing geographical barriers and the onset of Industry 4.0 means that achieving
operational excellence
is no longer just a strategic initiative; it is becoming a
survival tactic.
The cost of compliance and product traceability continues to mount as regulations grow increasingly stricter and counterfeiting becomes more innovative. These combined challenges are eroding profitability to unprecedented levels. In addition, the growing popularity of consumer medical devices has led to intensified demand for more sophisticated products, requiring ever more complex manufacturing and engineering processes.
The combined pressures not only threaten profitability, but also impact the ability of organizations to remain agile, innovative and competitive. In order to remain on the cutting edge, it is imperative that the medical device manufacturing industry changes its current approach to Manufacturing Operations Management (MOM).
The advanced technologies in Manufacturing Execution Systems (MES)/MOM will enable organizations to systematically enforce compliance, enhance product quality, eliminate waste and promote continuous improvement. MES is the solution to the current challenges being experienced by medical device manufacturers and will also ensure they achieve and sustain a state of
operational excellence
.
Some key ways MES benefits medical device manufacturers include:
*
Elimination of paper-based manufacturing processes which is error-prone and inhibits growth
*
Managing of greater product complexity and output throughout the manufacturing process
*
Agility, flexibility and continuous growth
*
Full traceability and product genealogy
Typical cost savings achieved through an MES being implemented are significant, including:
*
Overall cost of compliance
*
Savings in paper, printing and archiving
*
Wasted effort in handling and inspecting data entries in paper documents
*
ROI can be achieved on average of 12-18 months
MES solutions, coupled with appropriate operations strategies, can ultimately provide the right products with the right level of quality in the right quantity, at a price customers are willing to pay.